Depofort B12 Ampoule

  • Company Name: Pharco Pharmaceuticals
  • Trade Name: Depofort B12 Ampoule
  • Generic Name: Hydroxocobalamin

Composition: Each Ampoule (1 ml) contains:

  • Active ingredient:
    • Hydroxocobalamin acetate: 1.044 mg (equivalent to 1.0 mg Hydroxocobalamin)
  • Inactive ingredients:
    • Disodium hydrogen phosphate anhydrous
    • Sodium Chloride
    • Benzyl alcohol
    • Glacial acetic acid
    • Water for injection

Pharmaceutical Form: Ampoule

Pharmacological Action: Depofort B12 Ampoules contain hydroxocobalamin, a stable form of vitamin B12. Depofort B12 provides a continuous supply of vitamin B12, correcting and preventing deficiency. Vitamin B12 is essential for various metabolic functions, including metabolism of fats, carbohydrates, and protein synthesis. It plays vital roles in growth, cell reproduction, blood formation, and genetic material synthesis. Deficiency can lead to anemia and nerve damage. Treatment with Depofort B12 results in rapid improvement in blood and nerve health, increased strength, improved appetite, and well-being.

Depofort B12 injections are safe, well-tolerated, and cause no pain or irritation at the injection site.

Pharmacokinetics: Depofort B12 is well absorbed after intramuscular injection. In the blood, vitamin B12 binds to specific plasma proteins. It is stored in the liver, excreted in bile, and recycled. Hydroxocobalamin is excreted slowly due to high protein binding. Vitamin B12 crosses the placenta and appears in breast milk.

Indications

  • Treatment and prevention of vitamin B12 deficiency in conditions such as:
    • Pernicious and megaloblastic anemia
    • Gastric surgery or mucosal damage
    • Congenital malabsorption
    • Strict vegetarian diets
    • Tobacco amblyopia
    • Infection with intestinal parasites or bacteria
  • Increased requirements in conditions like:
    • Hemolytic anemia and hemorrhage
    • Thyrotoxicosis and malignancy
    • Hepatic and renal diseases
    • Cyanide toxicity with sodium nitroprusside
    • Neurological disorders

Dosage

  • For anemia and severe deficiencies: 1 ampoule (I.M.) every other day for 1-2 weeks, then 1 ampoule every 3 months for maintenance.
  • For neurological cases: 1 ampoule (I.M.) every other day until improvement is optimum.
  • For prophylactic use in anemia and mild deficiencies: 1 ampoule (I.M.) every 2-3 months.

Contraindications

  • Hypersensitivity to hydroxocobalamin or cobalt.

Side Effects: Depofort B12 is well tolerated. Rare hypersensitivity reactions may include itching, diarrhea, urticaria, or peripheral vascular thrombosis.

Drug Interactions: Chloramphenicol may interfere with the therapeutic response to hydroxocobalamin injection.

Warnings & Precautions

  • Do not administer to premature infants, neonates, infants below 13 years, pregnant women, or nursing mothers if preserved with benzyl alcohol.
  • Keep all medications out of reach of children.

Storage: Store at temperatures not exceeding 30°C and protect from light.

Issue date: 7/6/2010

Important Note: This medication affects your health, and misuse can be dangerous. Always follow your doctor’s prescription and consult your pharmacist for guidance. Do not interrupt treatment without consulting your doctor, and do not repeat prescriptions without medical advice. Your doctor and pharmacist are experts in medications and their risks and benefits.